Drive control mechanisms and automatic injectors for injectable cartridges

ABSTRACT

An automatic injector includes a housing having a guide, a drive control mechanism, a transmission assembly, a motor, and an energy source. The housing may further include a cartridge cover. A drive control mechanism includes a drive screw, a cartridge carrier, a plunger carrier, and one or more control transfer instruments, such as a puck or cylinder. The drive screw interfaces and connects with the plunger carrier. The automatic injector is configured to accept a variety of syringes as cartridges for drug delivery. The cartridges may be ejected from the injector and safely disposed after use, making the injector a reusable automatic injector. The reusable automatic injector may further include one or more sensors, such as a cartridge sensor and a patient sensor. The novel incorporation of the drive control mechanisms into the automatic injectors of the present invention enables a single motor and transmission assembly to drive the function of multiple components, which may include the steps of: preparation and alignment of a cartridge for injection, removal of a safety cap or needle shield, needle injection, drug dose delivery, and syringe and/or needle retraction. Methods of manufacture and methods of use are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/572,161, filed Dec. 16, 2014, which is a continuation of U.S.application Ser. No. 13/934,958, filed Jul. 3, 2013, now U.S. Pat. No.8,920,374, issued on Dec. 30, 2014, which claims the benefit of U.S.Provisional Patent Application No. 61/683,499, filed Aug. 15, 2012, andU.S. Provisional Patent Application No. 61/668,303, filed Jul. 5, 2012.The entire teachings of the above applications are incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates to reusable automatic injection devices.More specifically, the embodiments of the present invention relate toelectro-mechanical automatic injection devices which utilizemotor-driven drive mechanisms, incorporate replaceable injectionsyringes, and perform one or more of the steps of: preparation andalignment of the syringe for injection, removal of the safety cap,needle injection and drug dose delivery, and needle and/or syringeretraction. The present invention also relates to drive mechanisms forreusable automatic injection devices, methods for manufacturing suchdevices, and their methods of use.

BACKGROUND OF THE INVENTION

Manually activated pre-filled cartridges are commercially available froma variety of manufacturers, including the owner and assignee of thepresent invention. The owner and assignee of the present invention hasdeveloped a syringe which offers a unique and elegant integratedmechanism for retraction of the needle and/or syringe. Currently visual,tactile or audible indicators are generally linked to the end of strokeor some other mechanical mechanism and not to the end of dose. Theintegrated needle retraction syringe retracts the needle into thebarrel, removing it from the patient's skin, once the dose is complete.

Pre-filled cartridges are used in the administration of drug solutions,drug suspensions, vaccines, medicinal therapies, and any other liquidmedicament by parenteral injection. Such pre-filled cartridges include aprimary drug chamber, a hypodermic needle permanently affixed to and influid communication with the drug chamber, and a piston slidablyreceived in the drug chamber. The pistons of the pre-filled cartridgesoften include a plunger sub-assembly, which may include a plunger innerand a plunger outer, to force the liquid medicament from the needle.Pre-filled cartridges are typically prepared by pharmaceutical companiesor sterile filling contractors in a sterile filling room in which thedrug and the cartridge are brought together in a sterile manufacturingenvironment wherein all components and drug solutions are isolated frommicrobial contamination.

In contrast to manually activated pre-filled cartridges, automaticinjection devices, commonly known as “auto-injectors,” are alsoavailable. Such auto-injectors, once triggered by the user, use anautomatic mechanism to insert a hypodermic needle into the recipient'sflesh at the injection site and force the liquid medicament out of amedicine compartment, through the hypodermic needle, and into therecipient. In addition to automatic needle insertion and dose delivery,some auto-injectors also incorporate retraction mechanisms toautomatically retract the needle after use. Auto-injectors have provenparticularly useful in allowing the medically untrained user toadminister a parenteral injection, and can provide both psychologicaland physical advantages to patients.

Patients needing to inject medication for chronic disease managementhave used auto-injectors since the first reusable auto-injector wasintroduced in the 1990s. An auto-injector provides protection for theprimary container, generally a pre-filled syringe, and offers an easyway for automatic injection of medication. These devices offer increasedconvenience and autonomy for patients as well as providing a competitiveadvantage to the pharmaceutical partner through device differentiationand increased sales through compliance of the patient to their therapy.Auto-injectors may also be beneficial in delivering large volumes (up to1 mL currently) and viscous drugs. Auto-injectors also work to preventneedle stick injuries by housing the needle within a chamber, insertingthe needle into the patient for drug introduction, then retracting theneedle back into the housing utilizing, for example, reverse drivemechanisms.

Some auto-injectors have been designed to accept commercially available,manually activated pre-filled cartridges. Such configurations may bemade in the form of cartridges for auto-injectors (e.g., reusableauto-injectors) or single-use auto-injectors. The syringes developed andmanufactured by the owner and assignee of the present invention offerunique and elegant integrated retraction mechanism for needle safety. Anumber of different pre-filled syringes and cartridge configurations maybe utilized in such auto-injectors, including those sold by the assigneeand owner of the present invention under the trade name “Unifill” andcovered by one or more of the following: U.S. Pat. Nos. 6,083,199,7,500,967, 8,021,333, 8,002,745, 8,114,050, 8,052,654, 7,935,087, and8,167,937; U.S. Patent Pub. No. 2011/0015572; and International PCT App.Nos. PCT/AU2010/001505, PCT/AU2010/001677, and PCT/AU2011/000515, all ofwhich are incorporated herein by reference, in their entirety, for allpurposes.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to novel automatic injection devices fordrug delivery with incorporate a multifunctional drive controlmechanism. The components of the automatic injection devices areconfigured for repeatable functionality. Accordingly, the automaticinjectors of the present invention may be single-use devices but are,preferably, utilized as reusable automatic injectors. Accordingly, anumber of single-use syringes may be employed as cartridges with theautomatic injectors of the present invention. The reusableauto-injectors of the present invention could be adapted for use withany type of retractable or safety syringe, but for simplicity, theinvention is described when using a syringe similar to those sold by theowner and assignee of the present invention under the trade name“Unifill.” The automatic injectors are also designed to accept a varietyof syringes as drug-container cartridges.

The novel incorporation of the drive control mechanisms into theautomatic injectors of the present invention enables a single motor andgear to drive the function of multiple components, which may include thesteps of: preparation and alignment of a cartridge for injection, needleinjection, drug dose delivery, and syringe and/or needle retraction.Optionally, the automatic injector may also perform the step of, beforeneedle injection, removal of a safety cap or needle shield from thecartridge. Furthermore, optionally, the automatic injector may beconfigured to adjust the dose volume, such as by expending a portion ofthe drug dosage to a reservoir, prior to needle injection and drug dosedelivery into a user. Utilizing a single drive control mechanism tocontrol multiple device stages greatly simplifies the functionality ofthe automatic injector and improves the reliability, operation, andmanufacturing cost of the reusable automatic injector. Additionally, thenovel automatic injectors of the present invention are capable ofrepeatedly performing these tasks, making them reusable automaticinjectors. Embodiments of the novel automatic injectors of the presentinvention may be capable of accomplishing all of these advantages whilealso maintaining an appearance and size comparable to existing productsin the market. The simplicity and reusability of these automaticinjectors facilitate ease-of-use and patient acceptance, both criticalmetrics for overall patient care and at-home use of the automaticinjectors.

In one embodiment, the present invention provides a drive controlmechanism for an automatic injector which includes a drive screw, acartridge carrier, a plunger carrier, and one or more control transferinstruments. A motor with a gear train, including one or more gears,connected, either directly or indirectly, to the drive screw may be usedto control the motion of the cartridge carrier and the plunger carrier.

The control transfer instruments may be, for example, a spherical ball,a cylinder, a disc or chip, or similar instruments that may freely movebetween the other components of the drive control mechanism. The controltransfer instrument may preferably be cylinders (e.g., “pucks”). Forsimplicity, the control transfer instruments may be referred to hereinas the “puck” or “pucks,” though the actual shape and dimensions mayvary from that of standard cylindrical objects. The transfer instrumentfunctions to control the action of the components of the drive controlmechanism by locking between two objects and causing them to move, orstay in a fixed position, as one unit. The transfer instrument may beretained in an annular space within, or between, the components of thedrive control mechanism. In an embodiment, the plunger carrier containsa plunger carrier recess, while the cartridge carrier contains achannel, within both of which the transfer instrument may movably resideto control the operation of the drive control mechanism. Optionally,additional components may be utilized to retain the transfer instrumentin a position from which it can control the control transfer function.For example, a guide having a guide recess may be employed for thispurpose.

In an embodiment, the drive control mechanism for an automatic injectorincludes a drive screw, a cartridge carrier, a plunger carrier, a guide,and two control transfer instruments. The control transfer instrumentsmay be a number of different shapes including, for example, pucks. Thetransfer instruments may be retained in annular spaces within, orbetween, the components of the drive control mechanism. The plungercarrier contains plunger carrier recesses, the cartridge carriercontains channels, and the guide has guide recesses for each transfercontrol instrument to interact with to control the operation of thedrive control mechanism.

For example, in an initial stage, the components of the drive controlmechanism are aligned such that the one or more control transferinstruments are allowed to freely pass between the guide recess and theplunger carrier recess through the channel of the cartridge carrier.When there are two or more control transfer instruments, there arecorresponding guide recesses, channels, and plunger carrier recesses foreach control transfer instrument. The plunger carrier recess and theguide recess can be a number of different configurations. In oneembodiment of the present invention, the plunger carrier recess and theguide recess are symmetrical carve-outs of their respective components.Each of the recesses may be, for example, ramped to force the motion ofthe transfer instrument “out” into the guide recess or “in” into theplunger carrier recess. As the drive screw is caused to move axially, byoperation of the motor and interaction with a gear or transmissionassembly, the transfer instrument may be forced out from the plungercarrier recess into position between the guide recess and the channel ofthe cartridge carrier. At another stage of operation the guide recessmay align with the channel of the cartridge carrier. By interaction ofother aspects of the guide and the cartridge carrier, as describedfurther below, the transfer instrument may be caused to move out of theguide recess and into position between the plunger carrier recess andthe channel of the cartridge carrier. This alignment may cause theplunger carrier and the cartridge carrier to move as one unified unit.While the plunger carrier and the cartridge carrier are movable objects,the guide remains a fixed object throughout the operation of the drivecontrol mechanism.

In another embodiment, the present invention provides an automaticinjector which includes a housing having a guide, a drive controlmechanism, a transmission assembly, a motor, and an energy source. Theautomatic injector may also contain certain standard features such as,for example, a microprocessor or similar control system which are knownto an ordinarily skilled artisan. The housing may further include acartridge cover. The drive control mechanism may include a number ofcomponents, including a drive screw, a cartridge carrier, a plungercarrier, and one or more control transfer instruments. The cartridgecarrier interfaces and connects with a cartridge, such as a syringe,which holds a drug treatment for delivery to a patient. Moreparticularly, a cartridge connection feature of the cartridge carrierconnects with a corresponding aspect of the cartridge. This can be, forexample, a tongue-and-groove connection as is known in the art. Thecartridge connection feature and cartridge carrier may be separatecomponents which are connected or are one unified component. Theautomatic injector may further comprise certain optional components suchas, for example, a cartridge sensor and a patient sensor, which aredescribed further below.

The motor may be an electric motor that is coupled with and powered bythe energy source. The energy source may be, for example, a disposablebattery or a rechargeable battery. The motor, drive control mechanism,and other components of the automatic injector may be employed toprovide the force required for multiple injections over an extendedperiod. A commercially available electric motor with both forward andreverse output shaft rotation may be used with a programmablecontroller, such as a microprocessor, to control the stages of operationrequired to perform the injection of the medicament and the retractionof the needle and/or syringe.

The reusable auto-injector could be adapted for use with any type ofretractable or safety syringe, but for simplicity, the invention isdescribed when using a syringe similar to those sold by the owner andassignee of the present invention under the trade name “Unifill.”Because the components of the automatic injector and the drive controlmechanism are able to repeatedly load, inject, and eject drug cartridgesfor injection of drug treatments to a patient, they are consideredreusable automatic injectors.

In another embodiment, the present invention relates to the method formanufacturing automatic injectors. The method includes the steps ofassembling a drive control mechanism which includes a drive screw, aplunger carrier, a cartridge carrier, and one or more control transferinstruments. The drive control mechanism may further include a guidehaving one or more guide recesses, one or more recess on the plungercarrier, and one or more channels within the cartridge carrier. The oneor more control transfer instruments may be, for example, a sphericalball, a cylinder, a disc or chip, or similar instruments that may freelymove between the other components of the drive control mechanism, butare preferably cylindrical pucks. These components are sized andconfigured such that the control transfer instrument is retained withinthe drive control mechanism and the guide. For example, the cartridgecarrier may be a thin object having rectangular bores through it aschannels. The transfer instruments may reside within the channels, butwould be prevented from moving laterally along the axial plane of thecarrier because they are retained on all four sides. The dimensions ofthe transfer instruments are such that the transfer instruments arealways removably engaged with two components of the drive controlmechanism and/or guide simultaneously. The method further includes thestep of attaching a guide and a housing to the drive control mechanism.The method may further include the steps of attaching one or more of: anenergy source, a motor, a transmission assembly, and a control systemsuch as a microprocessor, wherein the transmission assembly is made tocontact the drive screw. An injector or cartridge cover may also beattached to the automatic injector to facilitate loading and ejection ofthe cartridges.

In yet another embodiment, the present invention relates to a method ofuse for an automatic injector. The method includes the steps of:inserting a cartridge into a cartridge carrier contained in a housing ofthe automatic injector and activating the automatic injector toinitiate, optionally, one or more of: removal of a needle shield,injection of a needle into a patient, delivery of drug through theneedle to the patient, retraction of the needle from the patient intothe housing, and removal of the cartridge from the cartridge carrier.Furthermore, optionally, the method of use may include the step ofexpending a portion of the drug dosage to a reservoir or to theenvironment, prior to needle injection and drug dose delivery into auser, in order to reduce or adjust drug volume. The method may furtherinclude the steps of opening a cartridge cover to access an interior ofthe automatic injector prior to the insertion of a cartridge into thecartridge carrier, and the step of closing the cartridge cover after thecartridge has been loaded into the cartridge carrier. The method maysimilarly include the step of opening the cartridge cover to access aninterior of the automatic injector after the retraction of the needle toremove the used cartridge. The user may optionally reattach the needleshield to the cartridge after the syringe has been used (i.e., drugdelivery has completed). After the used syringe has been removed fromthe cartridge carrier of the automatic injector, the automatic injectoris reset and ready to accept another cartridge.

The embodiments shown and detailed herein disclose only a few possiblevariations of the present invention; other similar variations arecontemplated and incorporated within the breadth of this disclosure. Aswould be readily appreciated by an ordinarily skilled artisan, a numberof parameters, shapes, and dimensions described above may be modifiedwhile remaining within the breadth and scope of the present invention.

An automatic injector is adapted to receive a cartridge that includes abarrel, a needle, and a plunger assembly including a plunger seal. Thecartridge defines a longitudinal axis. The automatic injector includes ahousing, a cartridge carrier, and a plunger carrier. The cartridgecarrier is adapted to receive at least a portion of the cartridge. Thecartridge carrier is disposed for movement relative to the housing in adirection parallel to the longitudinal axis of the cartridge. Theplunger carrier is disposed for movement relative to the cartridgecarrier. The plunger carrier is disposed to confront and impart movementat least a portion of the plunger assembly. At least one transferinstruments is disposed to selectively couple the cartridge carrier tothe plunger carrier for movement therewith. An elongated drive device iscoupled to the plunger carrier. The elongated drive device is disposedto provide movement of the plunger carrier in a direction parallel tothe longitudinal axis of the cartridge.

A method of operating an automatic injector to inject a fluid from acartridge includes disposing the cartridge in the automatic injectorwith at least a portion of a barrel disposed within a cartridge carrier,and a plunger assembly disposed for confrontation with a plungercarrier, a needle end of the cartridge defining a distal end of theautomatic injector and the opposite end of the cartridge defining aproximal end of the automatic injector, coupling the cartridge carrierto the plunger carrier, utilizing a single drive mechanism to move theplunger carrier and the cartridge carrier to advance the cartridge in anaxial direction toward the distal end, decoupling the cartridge carrierfrom the plunger carrier, utilizing the drive mechanism to move theplunger carrier in the axial direction toward the distal end to dispensethe fluid, and retracting the plunger carrier in an axial directiontoward the proximal end.

A method of operating an automatic injector includes disposing a firstcartridge in a housing of the automatic injector, actuating theautomatic injector to dispense fluid from the first cartridge, removingthe first cartridge from the housing, disposing a second cartridge inthe housing, and actuating the automatic injector to dispense fluid fromthe second cartridge.

BRIEF DESCRIPTION OF THE DRAWING(S)

The following non-limiting embodiments of the invention are describedherein with reference to the following drawings, wherein:

FIG. 1 shows an isometric view of the reusable automatic injector,according to one embodiment, with an optional cartridge cover of thehousing closed and the injector ready for operation.

FIG. 2 shows an isometric view of the reusable automatic injector,according to one embodiment, with an optional cartridge cover of thehousing open for loading of a syringe cartridge.

FIG. 3 is a fragmentary view of a distal end of a reusable automaticinjector with the cartridge cover in a closed position.

FIG. 4 is an exploded isometric view of a housing and aspects of a drivecontrol mechanism according to an embodiment.

FIG. 5 shows an isometric view of the bottom of a reusable automaticinjector according to the embodiment shown in FIGS. 1-5.

FIG. 6 shows an isometric view of the components of the drive controlmechanism, motor, and transmission assembly according to one embodimentof the present invention.

FIGS. 7-8 show top and bottom views, respectively, of the componentsshown in FIG. 6.

FIG. 9 shows an isometric view of the cartridge carrier of the drivecontrol mechanism, according to one embodiment of the present invention.

FIGS. 10A-10E show expanded views of components of the drive controlmechanism of the reusable automatic injector, according to theembodiment shown in FIGS. 11-15, as they progress through the stages of:syringe cartridge loading, removal of rigid needle shield, needleinjection, drug dose delivery, and needle retraction.

FIG. 11A is a side view of the reusable automatic injector, according toone embodiment of the present invention, shown in the syringe cartridgeloading configuration.

FIG. 11B is a top view of the reusable automatic injector shown in FIG.11A.

FIG. 12A is a side view of the reusable automatic injector, according toone embodiment of the present invention, shown in the needle shieldremoval configuration.

FIG. 12B is a top view of the reusable automatic injector shown in FIG.12A.

FIG. 13A is a side view of the reusable automatic injector, according toone embodiment of the present invention, shown in the injectionconfiguration.

FIG. 13B is a top view of the reusable automatic injector shown in FIG.13A.

FIG. 14A is a side view of the reusable automatic injector, according toone embodiment of the present invention, shown in the drug deliveryconfiguration.

FIG. 14B is a top view of the reusable automatic injector shown in FIG.14A.

FIG. 15A is a side view of the reusable automatic injector, according toone embodiment of the present invention, shown in the syringe/needleretraction configuration.

FIG. 15B is a top view of the reusable automatic injector shown in FIG.15A.

FIGS. 16A-16B are side elevational views of a housing including anembodiment of a cartridge ejector in the loaded and unloaded positions,respectively.

FIG. 17 is a side elevational view of an alternate embodiment of anautomatic injector according to the invention.

FIG. 18 is an enlarged, fragmentary view of components of the drivecontrol mechanism of FIG. 17.

FIG. 19 is a bottom view of another embodiment of an automatic injectoraccording to the invention.

FIG. 20 is a top plan view of another embodiment of an automaticinjector according to the invention.

FIG. 21 is a top plan view of another embodiment of an automaticinjector according to the invention.

FIGS. 22A-22E are side elevational views of a housing illustrating acartridge cover release safety mechanism according to aspects of theinvention.

FIG. 23A is a side view of the reusable automatic injector, according toanother embodiment of the present invention having a permanent plungerrod;

FIG. 23B is a top view of the reusable automatic injector shown in FIG.23A.

DETAILED DESCRIPTION OF THE INVENTION

The embodiments of the present invention relate to automatic injectiondevices for drug delivery. The components of the automatic injectiondevices are configured for repeatable functionality, and the automaticinjectors are designed to accept a variety of drug containers, such assyringes, as cartridges. For the purposes of this disclosure, the term“cartridge” will refer generically to both syringes, which include aplunger rod for administration of a medicament from a barrel by movementof a plunger seal, and medicament containing barrels that do not includea plunger rod for activation of a plunger seal.

The automatic injectors of the present invention may be single-usedevices but are, preferably, utilized as reusable automatic injectors.More specifically, the embodiments of the present invention relate toelectro-mechanical automatic injection devices which utilizemotor-driven drive mechanisms, incorporate replaceable injectionsyringes, and perform one or more of the steps of: preparation andalignment of a cartridge for injection, removal of a safety cap orneedle shield, needle injection, drug dose delivery, and syringe and/orneedle retraction. The novel incorporation of the drive controlmechanisms into the automatic injectors of the present invention enablesa single motor and transmission assembly to drive the function ofmultiple components, thereby simplifying the functionality of the deviceand improving the reliability, operation, and manufacturing cost of thereusable automatic injector. The present invention also relates to drivemechanisms for automatic injection devices, methods for manufacturingsuch devices, and their methods of use. Furthermore, optionally, theautomatic injector may be configured to adjust the dose volume, such asby expending a portion of the drug dosage to a reservoir, prior toneedle injection and drug dose delivery into a user.

As used herein to describe the drive mechanisms, automatic injectors,cartridges, or any of the relative positions of the components of thepresent invention, the terms “axial” or “axially” refer generally to alongitudinal axis “A” around which reusable automatic injector ispreferably positioned although not necessarily symmetricallythere-around. The terms “proximal,” “rear,” “rearward,” “back,” or“backward” refer generally to an axial direction in the direction of theplunger rod or transmission assembly. The terms “distal,” “front,”“frontward,” “depressed,” or “forward” refer generally to an axialdirection in the direction of the needle or rigid needle shield. Theterm “laterally” refers to a direction in a plane normal to alongitudinal axis “A.” The term “radial” refers generally to a directionnormal to axis A.

As used herein, the term “glass” should be understood to include othersimilarly non-reactive materials suitable for use in a pharmaceuticalgrade application that would normally require glass. The term “plastic”may include both thermoplastic and thermosetting polymers. Thermoplasticpolymers can be re-softened to their original condition by heat;thermosetting polymers cannot. As used herein, the term “plastic” refersprimarily to moldable thermoplastic polymers such as, for example,polyethylene and polypropylene, or an acrylic resin, that also typicallycontain other ingredients such as curatives, fillers, reinforcingagents, colorants, and/or plasticizers, etc., and that can be formed ormolded under heat and pressure. As used herein, the term “plastic” doesnot include either glass or elastomers that are approved for use inapplications where they are in direct contact with therapeutic liquidsthat can interact with plastic or that can be degraded by substituentsthat could otherwise enter the liquid from plastic. The term“elastomer,” “elastomeric” or “elastomeric material” refers primarily tocross-linked thermosetting rubbery polymers that are more easilydeformable than plastics but that are approved for use withpharmaceutical grade fluids and are not readily susceptible to leachingor gas migration.

“Fluid” refers primarily to liquids, but can also include suspensions ofsolids dispersed in liquids, and gasses dissolved in or otherwisepresent together within liquids inside the fluid-containing portions ofcartridges. The terms “drug,” “medicine,” and “medicament” are used torefer to any substance that is administered from a cartridge through aneedle or cannula, and is not limited to pharmaceutical substances, butmay include, for example, vitamins or minerals.

As used herein, the terms “automatic injector” and “auto-injector” aremeant to refer to the same reusable devices, which may also be referredto by the acronym “RAI”. “Puck” is used herein to describe a componentof the drive control mechanism, but the term is not limited to such ashape and, in one or more embodiments of the present invention, may be aspherical ball, cylinder, conoid, or other functional shape that can becaused to move freely when acted upon by one or more adjacentsurface(s).

Turning first to FIGS. 1 and 2, there is shown an automatic injector 50according to the invention. The automatic injector 50 includes a housing52 adapted to receive and support a syringe or cartridge 54 forinjection, as well as various components of the injection system. Avariety of cartridges 54 may be utilized in the reusable automaticinjector 50 of the present invention, including those having automaticretraction features. For example, a safety syringe with integratedneedle retraction may be used with the reusable automatic injector 50.One example of such a cartridge 54 in the form of a safety syringe isillustrated in FIG. 2 and in FIGS. 11A-15B, and includes a barrel 56, aneedle 58, a rigid needle shield 60, and a plunger assembly 62 includinga plunger seal 64, a plunger rod 66, and a plunger head 68. Thecartridge 54 includes a longitudinal axis A. In the illustratedembodiment, the barrel 56 of the cartridge 54 includes an enlargedfinger flange 70, such as is commonly used in standardized barrel 56designs. The cartridge 54 can be pre-filled with a drug or filledat-time-of-use by a user, that is, just prior to placement within thereusable automatic injector 50. Alternate embodiments of cartridges 54may include, by way of example only, cartridges 54 having a barrel 56sealed by a plunger seal 64, but having no plunger rod 66 (see, e.g.,FIG. 21 and explanation below).

The housing 52 may optionally be covered by a cartridge cover 72, whichmay likewise be of any appropriate design. In order to allow the user toview the status of the automatic injector 50, the cartridge cover 72 maybe entirely or partially translucent or transparent. Alternately, it maybe entirely or partially opaque. The cartridge cover 72 of FIGS. 1 and 2includes a window 74 that is disposed substantially adjacent the barrel56 of a supported cartridge 54, allowing the user to view the status ofdrug delivery. Optionally, the window 74 or portion of the cartridgecover 72 adjacent the window may have dose indication markings to allowthe user to identify the drug dose volume contained in the cartridge 54prior to, during, and/or after drug delivery.

In the illustrated embodiment, the cartridge cover 72 is hinged to thehousing 52, although an alternate arrangement may be provided. Forexample, the either the cartridge cover 72 or the housing 52 may includemating protrusions and the other of the cartridge cover 72 or thehousing 52 may include detents for receiving the protrusions. Suchprotrusions and detents may be provided alone, or in conjunction with ahinge arrangement, and may be provided at any appropriate locationbetween the housing 52 and the cartridge cover 72. In one suchembodiment, as shown in FIG. 3, a distal detent 76 with matingprotrusion 78 may be disposed at or substantially near the distal end ofthe automatic injector 50 to ensure that the distal end of the cartridgecover 72 is held rigidly to the housing 52, and provide secure closurealong substantially the entire contacting surface between the cartridgecover 72 and the housing 52. While the housing 52 and cartridge cover 72may be formed as separate components, the cartridge cover 72 and thehousing 52 may alternatively be formed as a single unit, coupled by aso-called living hinge (not illustrated).

The automatic injector 50 may further include a casing body 80, whichprovides a smooth outer appearance to the housing 52. The casing body 80may be formed as a separate structure from the housing 52 that presentsan internal chamber that receives the housing 52, or the housing 52 andthe casing body 80 may be formed as a single unit. It will beappreciated that, when the automatic injector 50 includes a cartridgecover 72, the cartridge cover 72 may be coupled to the housing 52 by wayof the casing body 80. That is, the cartridge cover 72 may be coupled tothe casing body 80, which receives the housing 52. As with the housing52 and the cartridge cover 72, the casing body 80 and the cartridgecover 72 may be formed separately, or as a single unit, connected, forexample, by a living hinge (not illustrated).

In the embodiment illustrated in FIGS. 1 and 2, the cartridge cover 72is held in a closed position over the housing 52 by a selectivelyactuable latch 86. In the illustrated embodiment, the cartridge cover 72includes a protrusion 88 that is received by a recess 90 in the housing52. A latch release 92 may be slid to the side or depressed to allow thecartridge cover 72 to be latched to or unlatched from the housing 52.

The automatic injector 50 may further include a user interface 96 withfeatures such as a release actuator 98 that may be depressed to initiateoperation of the automatic injector 50 or selection of other operativefeatures. Other operative features may include, by way of example only,an identification of the adjustments based upon the needle 58 utilizedin the cartridge 54, or volume of medicament carried in the cartridge 54and the volume to be dispensed, as will be explained in greater detailbelow. The automatic injector 50 may further include one or more lights100, or the like, indicating the state of operation of the automaticinjector 50.

The housing 52 may be of any appropriate design, and may be formed as aunitary structure, or it may include a plurality of components.Referring to FIGS. 4 and 5, the housing 52 is an elongated frame 102adapted to removably support a cartridge 54 along the upper surface oralong structure associated with the housing 52. The housing 52 mayfurther support one or more of the structures associated with theoperation or usage of the automatic injector 50. More specifically, inthe embodiment illustrated in FIG. 5, the housing 52 additionallysupports a drive control mechanism 104 that controls movement ofcomponents of the cartridge 54 within the housing 52. The drive controlmechanism 104, which will be described in greater detail below, may beoperated by motor 106 powered by an energy source 108. While the motor106 and energy source 108 are illustrated as being supported on thehousing 52, they could alternately be otherwise supported, for example,within a casing body 80. The energy source 108 may be in a number ofdifferent configurations and a variety of sources including, forexample, disposable batteries, or rechargeable and reusable batteries. Atransmission assembly 110 couples the rotary motion of the motor 106 tothe drive control mechanism 104.

The reusable automatic injector 50 may also contain certain standardfeatures such as, for example, one or more control systems, such as amicroprocessor (not specifically illustrated), may be used to controlthe timing and parameters of operation of the automatic injector 50.Operation of the control systems may optionally be based upon feedbackfrom one or more sensors, or input received from the user by way of theuser interface 96. For example, the automatic injector 50 may includefeatures that are associated with the closure of the cartridge cover 72to the housing 52, or the position of the latch release 92. In order tominimize the opportunity for inadvertent actuation of the automaticinjector 50, an optional sensor may be utilized to signal whether thecartridge cover 72 is open or closed, allowing a control systemassociated with the automatic injector 50 to prevent actuation if thecartridge cover 72 is not closed. Similarly, structure of the automaticinjector 50 or the control system may be designed to prevent opening ofthe cartridge cover 72, that is, movement of the latch release 92,unless the internal components are in one or more particular positions.

The microprocessor may be configured to receive feedback from theindividual sensors, and to cause certain activity of the motor 106 andtransmission assembly 110 based on varying feedback from one or moresensors. The attached figures exclude such control systems, as a numberof different systems or configurations may be employed, but a controlsystem should be understood as being optionally included. The controlsystem, as would readily be appreciated by one having ordinary skill inthe art, would accept some user activity at one or more system controlsand interpret such activity by the user to activate the features of thereusable automatic injector 50. In at least one embodiment, the controlsystem is a microprocessor located at the proximal end of the automaticinjector 50 adjacent the transmission assembly 110 and the userinterface 96 (shown in FIG. 2-10).

According to an aspect of embodiments of the invention, the automaticinjector 50 provides predicable movement for actuation of a loadedcartridge 54. In some embodiments, the automatic injector 50 providesrepeatable movement, such that the automatic injector 50 may be utilizedrepeatedly with a plurality of cartridges 54. In order to inject apatient, the automatic injector 50 proceeds through a plurality ofstages that include movement of the needle 58 into a target tissue, andadministration of an injection by movement of the plunger seal 64.

In order to provide longitudinal movement of components of the cartridge54 relative to the housing 52, the housing 52 supports the drive controlmechanism 104 that interfaces with the motor 106 via the transmissionassembly 110. The transmission assembly 110 may have a number ofconfigurations which enable it to transfer motion and energy from themotor 106 to the drive control mechanism 104. An exemplary transmissionassembly 110 is shown in greater detail in FIGS. 5-8. FIGS. 7-8 show thecomponents of the drive control mechanism 104 and transmission assembly110 illustrated in the isometric views of FIGS. 5-6 from top and bottomviewing angles. The transmission assembly 110 includes a gear train 112that transmits rotary motion from the motor 106 to an elongated drivedevice, here, a drive screw 114, that interfaces with the drive controlmechanism 104. The elongated drive device, here, the drive screw 114, isdisposed to impart movement to at least a portion of the plungerassembly 62 by way of the drive control mechanism 104. The drive controlmechanism 104 will be described in greater detail below.

It will be appreciated that the gear train 112 may have a number ofconfigurations which enable it to transfer motion and energy from themotor 106 to the drive screw 114. For example, the gear train 112 may bea simple gear or a pair of bevel gears that transfer motion from a motor106 to a drive screw 114. Referring to FIGS. 5-8, in particular, in atleast one embodiment of the present invention, the transmission assembly110 includes a pinion gear 116 connected to the motor 106, a compoundgear 118, and a drive gear 120. The compound gear 118 may have a primarygear surface 122 which engages the pinion gear 116, and a secondary gearsurface 124 which engages the drive gear 120. The drive gear 120 isconnected to the drive screw 114. It will be appreciated that as themotor 106 rotates the pinion gear 116 in a clockwise direction, forexample, the teeth of the pinion gear 116 engage the teeth of primarygear surface 122 of the compound gear 118, rotating the compound gear118 in a counterclockwise direction. As a result, the teeth of secondarygear surface 124 engage with the teeth of the drive gear 120 to rotatethe drive gear 120, as well as the connected drive screw 114 in aclockwise direction.

This configuration of the transmission assembly 110 enables motion ofthe motor 106 to control motion of the drive screw 114 in a manner whichminimizes the internal volume of the automatic injector 50 because boththe motor 106 and drive screw 114 can be positioned in an axialalignment. As would be readily appreciated by a skilled artisan, motionof the drive screw 114 by the transmission assembly 110 is caused by theinteraction between the teeth of the gears of the transmission assembly110. The teeth of one or more of these gears may be radial to the centerpoint of each gear, commonly referred to as “spur gears,” or they be anumber of other gear types known to one having ordinary skill in theart.

An exemplary drive control mechanism 104 is shown in more detail inFIGS. 6-9. The drive control mechanism 104 includes a cartridge carrier126, a plunger carrier 138 disposed to provide longitudinal movementrelative to the cartridge carrier 126, and a transfer instrument 150disposed to control relative movement between the plunger carrier 138and the cartridge carrier 126.

The cartridge carrier 126 includes an elongated frame 128 having acartridge connection feature 130. In the illustrated embodiment, theelongated frame 128 includes a pair of rails 132 with the cartridgeconnection feature 130 disposed at a distal end thereof. The cartridgeconnection feature 130 is adapted to interface with and support aproximal end of the barrel 56 of the cartridge 54. In the illustratedembodiment, the cartridge connection feature 130 includes an internalchannel 134 adapted to receive the enlarged finger flange 70 of thecartridge 54. The cartridge connection feature 130 may include, forexample, a tongue-and-groove connection or any other removably engagingconnection feature known in the art. It will be appreciated by those ofskill in the art that an alternate coupling may be provided at theillustrated or an alternate position, so long as the movement of thecartridge carrier 126 in the proximal or distal direction results in acorresponding movement of the barrel 56 of the cartridge 54.

In order to provide for movement of the cartridge 54 to facilitate, forexample, insertion of the needle 58 into target tissue, the cartridgecarrier 126 is mounted for axial movement relative to the housing 52. Inthe illustrated embodiment, the housing 52 includes a pair oflongitudinally extending rails 136 along which the elongated frame 128of the cartridge carrier 126 ride. It will be appreciated, however, thatthe relative axial movement may be facilitated by any appropriatestructural arrangement. In this way, during one or more stages of theoperation of the automatic injector 50, such as the insertion andremoval of a needle 58 from target tissue, the cartridge carrier 126 maymove the barrel 56 of the loaded cartridge 54 in the proximal or distaldirection relative to the housing 52.

To allow for administration of a medicament, the drive control mechanism104 provides for the longitudinal movement of the plunger seal 64 withinthe barrel 56 of the cartridge 54. In the illustrated embodiment, thedrive control mechanism 104 includes a plunger carrier 138 that receivesthe plunger head 68 connected to the plunger rod 66. The illustratedplunger carrier 138 includes an interface feature 140 that confronts atleast a portion of a proximal end of the plunger assembly 62, here, theplunger head 68. In this way, movement of the plunger carrier 138 in thedistal direction causes the plunger head 68 and the plunger rod 66causes the plunger seal 64 to move in a distal direction within thebarrel 56 to administer a medicament.

Returning to the embodiment illustrated in FIGS. 4 and 6-8, to dispensemedication from the cartridge 54, the plunger carrier 138 is mountedsuch that operation of the motor 106 by way of the transmission assembly110 and drive screw 114 results in longitudinal movement relative to thehousing 52. As may best be seen in FIG. 4, the plunger carrier 138includes an internally threaded bore 142 that is complimentary to theexternally threaded drive screw 114. In the illustrated embodiment, theinternally threaded bore 142 extends through a portion 144 of theplunger carrier 138 that is disposed between the rails 132 of thecartridge carrier 126 such that the a cradle 146 of the plunger carrier138 rides along an upper surface of the rails 132 while portion 144rides between the rails 132.

As the drive screw 114 rotates, the plunger carrier 138 travels in alongitudinal direction dependent upon the direction of the rotation ofthe drive screw 114 as well as the configuration of the threads on theexternally threaded drive screw 114 and in the internally threaded bore142. The interaction and rotation of the gears of the gear train 112,driven by the motor 106, drive the operation of the automatic injector50 as they rotate the drive screw 114. For example, based upon theillustrated thread configuration and viewing the automatic injector 50from the proximal end, clockwise rotation of the motor 106 causes thedrive screw 114 to move the plunger carrier 138 of the injector 50 inthe proximal direction relative to the housing 52 as the drive screw 114rotates in a clockwise direction; conversely, counterclockwise rotationof the motor 106 causes the drive screw 114 to rotate in acounterclockwise direction to move the plunger carrier 138 in the distaldirection relative to the housing 52. Should the drive screw 114 and theinternally threaded bore 142 of the plunger carrier 138 each have anopposite thread configuration to that illustrated, the direction ofmovement of the plunger carrier 138 in the proximal or distal directionrelative to the housing 52 would be the opposite.

In other words, operation of the motor 106 rotates the drive screw 114by way of the transmission assembly 110, and rotation of the drive screw114 moves the plunger carrier 138 in the longitudinal direction withinthe housing 52. In the illustrated embodiment, this movement of theplunger carrier 138 is likewise utilized to provide selectivelongitudinal movement to the cartridge carrier 126 to allow for movementof the needle 58 into and out of target tissue. In order to transmitthis movement from the plunger carrier 138 to the cartridge carrier 126,one or more transfer instruments 150 are provided. As will be explainedin greater detail below, the transfer instrument 150 may be movedselectively between a first position wherein the transfer instrument 150engages only one of the either the cartridge carrier 126 or the plungercarrier 138, and a second position wherein the transfer instrument 150engages both of the cartridge carrier 126 and the plunger carrier 138,in effect, connecting the cartridge carrier 126 and the plunger carrier138 together for contemporaneous movement.

To provide this selective engagement, the transfer instrument 150 ismoveably disposed within a channel 152 of the cartridge carrier 126 (seeFIG. 9). The transfer instrument 150 is adapted to move laterallypartially into detents or recesses 154, 156 in the plunger carrier 138and guides 158 of the longitudinally extending rails 136 of the housing52, respectively. In this way, when the transfer instrument 150 isdisposed within the channel 152 of the cartridge carrier 126 and therecess 154 of the plunger carrier 138, the cartridge carrier 126 will becoupled to the plunger carrier 138 for movement with the plunger carrier138 along the drive screw 114. Conversely, when the transfer instrument150 is disposed within the channel 152 of the cartridge carrier 126 andthe recess 156 of the guide 158, the cartridge carrier 126 will nottravel with the plunger carrier 138; rather, in the illustratedembodiment, the cartridge carrier 126 will not move relative to thehousing 52.

It will be appreciated by those of skill in the art that each of therecesses 154, 156 and the channel 152 could be described as openings.Further, it will be appreciated that, while the transfer instrument 150is described herein as moving between a first position within thechannel 152 of the cartridge carrier 126 and the recess 156 of the guide158 to a second position within the recess 154 of the plunger carrier138 and the channel 152 of the cartridge carrier 126, in an alternateembodiment, the transfer instrument 150 could disposed for movementbetween a first position within the recess 154 of the plunger carrier138 to a second position within the recess 154 of the plunger carrier138 and the channel 152 of the cartridge carrier 126.

Further, while the transfer instrument 150 may be described as beingdisposed or engaged in the channel 152 and one or the other of therecesses 154, 156, the transfer instrument 150 may be slightly largerthan the combined the channel 152 and the one or the other of therecesses 154, 156. For the purposes of this disclosure and the appendedclaims, however, when the transfer instrument 150 is described as beingdisposed or engaged in one or the other of the recesses 154, 156 or inthe first or second position, it will be understood that the terminologyencompasses a structural relationship wherein the transfer instrument150 is predominately disposed one way or the other such that theassociated structures are substantially coupled together. That is, whenthe transfer instrument 150 is predominately disposed within the channel152 and the recess 154, the plunger carrier 138 and the cartridgecarrier 126 are coupled together; conversely, when the transferinstrument 150 is predominately disposed within channel 152 and therecess 156, the cartridge carrier 126 and the guide 158 are coupledtogether.

For clarity, FIGS. 10A-10E show components of the drive controlmechanism 104, and their relative positions as they move during stagesof actuation of the automatic injector 50. The illustrated embodimentincludes two control transfer instruments, specifically two transferinstruments 150 that move through respective channels 152 in thecartridge carrier 126 between respective recesses 154, 156 in theplunger carrier 138 and the guides 158.

While the transfer instruments 150, channel 152, and recesses 154, 156may be of any appropriate design, in the illustrated embodiment, thetransfer instruments 150 have the shape of a cylinder, disc or puck,allowing it to move smoothly within the channel 152. Moreover, thetransfer instruments 150 may be of any appropriate material. By way ofexample only, the transfer instruments 150 may be formed of a polymer,stainless steel, or a silicone or rubbery material.

The dimensions of the transfer instruments 150 are such that thetransfer instrument is always removably engaged with at least twocomponents of the drive control mechanism 104 simultaneously. In somestages of operation each transfer instrument 150 is removably engagedwith the corresponding recess 156 of the guide 158 and channel 152(visible in FIG. 9) of the cartridge carrier 126. In other stages ofoperation, each transfer instrument 150 is removably engaged with thechannel 152 of the cartridge carrier 126 and the recess 154 of theplunger carrier 138. This novel configuration enables a single motor 106and transmission assembly 110 to drive the function of multiplecomponents, thereby simplifying the functionality of the automaticinjector 50 and improving the reliability, operation, and manufacturingcost of the reusable automatic injector 50.

Likewise, the recesses 154, 156 of the plunger carrier 138 and theguides 158 can be a number of different configurations. In oneembodiment of the present invention, the recesses 154, 156 of theplunger carrier 138 and the guides 158 are symmetrical within therespective components. The recesses 154, 156 have an arcuate shape thatis ramped on either side to facilitate movement of the transferinstrument 150 as the transfer instrument 150 rides along the rampedsurfaces. In this way, an at least partially rounded outer surface ofthe transfer instrument 150 may smoothly ride along the ramped surfaces.

Operation of the transfer instruments 150 and the respective movementsof the cartridge carrier 126 and plunger carrier 138 may be betterunderstood with respect to exemplary stages of operation of theautomated injector 50. FIGS. 10A-10E and 11A-11B through 15A-B show thepositioning of components of an embodiment of the automated injector 50through the stages of cartridge 54 loading (FIGS. 10A and 11A-11B),removal of the rigid needle shield 60 (FIGS. 10B and 12A-12B), needle 58injection (FIGS. 10C and 13A-13B), drug dose delivery (FIGS. 10D and14A-14B), and needle retraction (FIGS. 10E and 15A-15B). FIGS. 11A, 12A,13A, 14A, and 15A show the automatic injector 50 from a side view(cross-sectional lines having been eliminated in the interest ofclarity), while FIGS. 11B, 12B, 13B, 14B, and 15B show automaticinjector 50 from a top plan view. FIGS. 10A-10E show enlargedfragmentary top views of the operation of the transfer instruments 150relative to the cartridge carrier 126, plunger carrier 138, and guides158. For the sake of clarity, the plunger carrier 138 is broken awaybelow the cradle 146, illustrating only the portion 144 of the plungercarrier 138 that rides between the rails 132 of the cartridge carrier126.

A cartridge 54 is replaceably inserted into a cartridge carrier 126 ofthe reusable automatic injector 50 and held in place throughout theneedle 58 injection and retraction process, as shown in FIGS. 11-15. Thecartridge 54 may be held in place within the cartridge carrier 126 by,for example, one or more cartridge 54 connection features 130.

A cartridge sensor 160 positioned within the cartridge carrier 126 mayoptionally be utilized to sense when a cartridge 54 has been placedwithin the cartridge carrier 126 of reusable automatic injector 50. Inthe illustrated embodiment, the cartridge sensor 160 is disposed at thebottom of the housing 52, although it may be alternately positioned.Placement of the cartridge 54 within the cartridge carrier 126 such thatthe cartridge sensor 160 senses the presence of the cartridge 54 mayprovide an indication that permits the reusable automatic injector 50 tobe activated.

The cartridge sensor 160 may be of any appropriate design. For example,the cartridge sensor 160 may be a mechanical sensor, such that placementof a cartridge 54 into the cartridge 54 carrier causes the displacementof the mechanical sensor. Alternatively, or additionally, the cartridge54 sensor may be an electrical sensor.

Further, actuation of the cartridge sensor 160, whether electrical ormechanical, may be tied to operation of the automatic injector 50 suchthat actuation of the cartridge sensor 160, for example, allows thecartridge cover 72 to close and latch, or provides a signal to aprocessor allowing actuation of the automatic injector 50. Uponactivation, the motor 106 may cause the transmission assembly 110 todrive the drive screw 114 into the correct position where the plungerinterface feature 140 of the plunger carrier 138 is in contact with, oradjacent to, the proximal end of the plunger rod 66 of the cartridge 54.

In order to facilitate removal of the rigid needle shield 60, theautomated injector 50 may include structure that engages the rigidneedle shield 60 such that movement of the cartridge 54 in the proximaldirection results in removal of the rigid needle shield 60. As may beseen in FIGS. 11A and 11B, the cartridge 54 may be positioned such thatthe rigid needle shield 60, which covers the needle 58 prior toinjection for safety purposes, is removably locked into needle shieldstripper features 162 of support housing 52. The needle shield stripperfeatures 162 may be of any appropriate design. In the illustratedembodiment, for example, the needle shield stripper features 162 includeone or more flanges 164 disposed along a proximally disposed edge ofrigid needle shield 60. In this way, as the flanges 164 confront therigid needle shield 60 during movement of the cartridge 54 in a proximaldirection, the rigid needle shield 60 is disengaged from the distal endof the cartridge 54. Alternatively, the reusable automatic injector 50may be configured such that the needle shield stripper features 162 ofsupport housing 52 lock onto the barrel 56 between the barrel 56 and therigid needle shield 60.

The function of the drive control mechanism, its components, and theautomatic injector 50 may be better understood with reference to FIGS.4, 6-8, and 10A-10E as they relate to FIGS. 11A-15B. In a first stage,typically for loading of a cartridge 54 into the automatic injector 50,the components of the drive control mechanism 104 are as shown in FIGS.10A and 11A-11B. The guide 158 contains the recess 156, while theplunger carrier 138 similarly contains recess 154. As described herein,the guide 158 may be a separate component or a pre-formed aspect of thehousing 52. Regardless of whether the guide(s) 158 are separatecomponents or pre-formed aspects of the housing 52, they are consideredas a part of the housing 52 for the purposes of this disclosure. Thecartridge carrier 126 contains at least one channel 152. The drivecontrol mechanism 104 may include a recess 156 within the guide 158, arecess 154 within the plunger carrier 138, and a channel 152 through thecartridge carrier 126 for each control transfer instrument 150 utilizedby the automatic injector 50. For example, when two puck-shaped controltransfer instruments are utilized in the automatic injector 50, as isshown in FIGS. 10A-10E, the drive control mechanism 104 includes twoguide recesses 156, two plunger carrier recesses 154, and two channels152 which are positioned and interact with the control transferinstruments 150, respectively. When the reusable automatic injector 50is in the first stage for cartridge 54 loading, the components of thedrive control mechanism 104 are aligned such that each transferinstrument 150 is allowed to freely pass between the guide recess 156,through the channel 152 of the cartridge carrier 126, and the plungercarrier recess 154, as illustrated in FIG. 10A.

To move the reusable automatic injector 50 into a second stage,generally considered the stage for removal of the rigid needle shield 60from the needle 58, motor 106 and transmission assembly 110 cause thecomponents of the drive control mechanism 104 to move in the proximaldirection. This arrangement is shown in FIGS. 12A and 12B. While therigid needle shield 60 is retained at the distal end of the reusableautomatic injector 50, such as by interaction with the needle shieldstripper features 162 of the support housing 52 for example, thecomponents of the drive control mechanism 104 and the cartridge 54 arecaused to move in the proximal direction. This action separates therigid needle shield 60 from the needle 58. In an embodiment, the rigidneedle shield 60 may be configured to “pop off” of the cartridge 54,such that the rigid needle shield 60 may be ejected from the reusableautomatic injector 50, if desired. The cartridge 54 and the automaticinjector 50 are now ready for injection into a patient.

FIG. 10B further details the interaction of the components of the drivecontrol mechanism 104 as the automatic injector 50 moves from theloading stage (shown in FIGS. 11A and 11B) to the removal of the rigidneedle shield 60 stage (shown in FIGS. 12A and 12B). While the guide158, and accordingly the guide recesses 156, is a fixed positioncomponent, the cartridge carrier 126, plunger carrier 138, and drivescrew 114 are all movable components. In the transition from the loadingstage to the removal of the rigid needle shield 60 stage, the motor 106and transmission assembly 110 cause the drive screw 114 to rotate suchthat the plunger carrier 138 is caused to move in the proximaldirection, that is, from the respective positions illustrated in FIG.10A to the respective positions illustrated in FIG. 10B. As the plungercarrier 138 moves rearward and the channel 152 of the cartridge carrier126 becomes aligned with the recesses 154 of the plunger carrier 138,the transfer instruments 150 move inward, ensuring that the transferinstruments 150 are out of guide recesses 156 and into position betweenthe channels 152 of the cartridge carrier 126 and the recesses 154 ofthe plunger carrier 138, as shown in FIG. 10B.

When the transfer instrument 150 is formed of a rubbery material and isslightly wider than the combined depth of the channel 152 and the guiderecess 156, the transfer instrument 150 will protrude slightly into therecess 154 of the plunger carrier 138 when the recess 154 aligns withthe recess 156 and the channel 152. As the plunger carrier 138 continuesto move relative to the guide 158, the cartridge carrier 126 may moveslightly with the plunger carrier 138 as a result of the force of thetransfer instrument 150 acted upon by ramped surface of the recess 154of the plunger carrier 138. The continued force of the ramped surface ofthe recess 154, the force of the ramped surface of the recess 156 in theopposite direction along an opposite side of the transfer instrument150, creates a moment that causes the transfer instrument 150 to movefrom the recess 156 of the guide 158 into the recess 154 of the plungercarrier 138. With the placement of the transfer instrument 150 in thechannel 152 of the cartridge carrier 126 and the recess 154 of theplunger carrier 138, the cartridge carrier 126 and plunger carrier 138are coupled together for further movement.

This positioning of the transfer instruments 150 causes the cartridgecarrier 126 and the plunger carrier 138 to move as one unifiedcomponent. That is, as rotation of the drive screw 114 causes movementof the plunger carrier 138 in the proximal direction, the positioning ofthe control transfer instruments 150 with the recesses 154 of theplunger carrier 138 and the channels 152 of the cartridge carrier 126couples the cartridge carrier 126 to the plunger carrier 138 so that thecartridge carrier 126 to also move in the proximal direction. In thisway, motion of the plunger carrier 138 and the cartridge carrier 126 inthe proximal direction moves the transfer instruments 150 away from therecesses 156 of the fixed position guide 158.

As stated above, one or more control transfer instruments 150 may beused in the drive control mechanisms and automatic injectors of thepresent invention. In at least one embodiment, however, two puck-shapedcontrol transfer instruments are utilized to, for example, providestronger connections, more even distribution of force on the components,and control the motion of the components.

Because the needle shield 60 of the cartridge 54 is removably confrontedby the needle shield stripper features 162 of the housing 52 (shown inFIGS. 11A-11B), the rigid needle shield 60 is removed from the needle 58by the proximal movement of the cartridge carrier 126 and the cartridge54. This is shown in the transition between FIGS. 11A-11B and 12A and12B, as well as the transition between FIGS. 10A and 10B. The reusableautomatic injector 50 can now be placed in contact with target tissue ofa patient to inject the needle 58 and deliver a drug contained withinthe cartridge 54.

Moving to FIGS. 13A-13B, during the injection stage, the cartridgecarrier 126 and the plunger carrier 138 are caused to move in the distaldirection, moving the now exposed needle 58 at the distal end of thereusable automatic injector 50 into an injection position in the targettissue of the patient. As described further herein, an optional patientsensor 165 (shown in FIGS. 1, 2 and 5) may be utilized to sense contactwith the patient prior to operation of the injection stage. The patientsensor 165 may be positioned at the distal end of the reusable automaticinjector 50, adjacent to and on the exterior side of the needle shieldstripper feature 162 of the support housing 52. Upon contact with apatient, the patient sensor 165 may signal a control system that thepatient is ready for injection, if one or more control systems areutilized to control the timing and parameters of motion. Alternatively,or additionally, the patient sensor 165 may be mechanically coupled toan arrangement that prevents administration of the drug from thecartridge 54 unless the patient sensor 165 is depressed.

As the cartridge carrier 126 and the plunger carrier 138 move in thedistal direction, the components move from the position shown in FIG.10B to the position shown in 10 c. As shown in FIG. 10C, at the positionwherein the needle 58 has been inserted into the target tissue, thechannels 152 again align with the recesses 156 in the guides 158. As aresult, the transfer instruments 150 are able to move freely between theplunger carrier recesses 154, the channels 152, and the guide recesses156. The transfer instruments 150 may be in the “out” position (i.e., inthe guide recesses 156) or in the “in” position (i.e., in the plungercarrier recesses 154). As the cartridge carrier 126 is moved into thefurthest distal position as illustrated in FIGS. 13A and 13B, however,the plunger carrier 138 continues forward movement as a result of therotation of the drive screw 114. With continued motion of the plungercarrier 138, the transfer instruments 150 ride along ramped edges of therecesses 154 of the plunger carrier 138, urging the transfer instruments150 outward through the channels 152 in the stationary cartridge carrier126 and toward the recesses 156 in the guides 158. In this way, thecontinued motion of the plunger carrier 138 causes the transferinstruments 150 to ride along the ramped sides of the recesses 154 ofthe plunger carrier 138 to move outward when the channels 152 of thecartridge carrier 126 are aligned with the recesses 156 of the guide158, disengaging the transfer instruments 150 from the recesses 154 inthe plunger carrier 138 to engage the transfer instruments 150 in therecesses 156 in the guide 158, that is, the position illustrated in FIG.10D. In the position of FIG. 10D, the plunger carrier 138 is free tocontinue forward movement for drug delivery.

Depending on the desired injection parameters, the drug may beimmediately delivered upon injection of the needle 58 or there may be amomentary delay between the two stages. Such parameters may beprogrammed into the control system or initiated by the user, as may bedesired for operation of the reusable automatic injector 50.

For the drug delivery stage, the plunger carrier 138 may continue tomove in the distal direction while the cartridge carrier 126 istemporarily locked into place with the guide 158, as illustrated in FIG.10D. The locking occurs because the transfer instruments 150 are forcedout of the plunger carrier recesses 154 and into position between thechannels 152 of the cartridge carrier 126 and the guide recesses 156 ofthe guide 158. As the plunger carrier 138 continues to move in thedistal direction, the plunger interface feature 140 of the plungercarrier 138 applies force to, or pushes upon, the distal end of theplunger rod 66. The plunger rod 66 relays that axial force in the distaldirection to the plunger seal 64 within the barrel 56 of the cartridge54, thereby forcing the drug fluid through the needle 58 and into thepatient.

Through the drug delivery stage, as the components of the automaticinjector 50 the transfer instruments 150 remains in the “out” positionbetween the channels 152 and the guide recesses 156, as shown in FIG.10d . It will be appreciated, however, that as the plunger carrier 138moves to the position illustrated in FIGS. 14A and 14B, the portion 144of the plunger carrier 138 disposed between the guides 158 moves beyondthe position wherein the portion 144 causes an interference that wouldprevent the transfer instruments 150 from again traveling radiallyinward, that is, out of the recesses 156 in the guides 158 and thechannels 152 in the cartridge carrier 126.

While any appropriate arrangement may be provided to retain the transferinstruments 150 in position, in the illustrated embodiment, a retainer166 is provided. The retainer 166 may best be viewed in FIG. 4. By wayof a retainer biasing element 168, such as the illustrated spring, theretainer 166 is disposed and biased toward a position that at leastpartially covers the channels 152 in the cartridge carrier 126 when theplunger carrier 138 is moved distally to deliver a drug from thecartridge 54. In this way, the retainer biasing element 168 and retainer166 are configured to retain the transfer instruments 150 within thechannels 152 and the guide recesses 156. For example, as shown in FIG.10D, the retainer biasing element 168 is positioned at the proximal endof, and axially around, the drive screw 114 between the proximal end ofthe cartridge carrier 126 and the proximal end of the plunger carrier138. The retainer biasing element 168 is initially in a compressedposition, but is permitted to expand along the axis of the drive screw114 when the plunger carrier 138 has moved distally. The retainerbiasing element 168 acts upon the retainer 166 and moves the latter inthe distal direction when the plunger carrier 138 has moved distally. Asthe plunger carrier 138 moves in the distal direction along the axis ofthe drive screw 114 during controlled drug delivery, the retainer 166,urged distally by the retainer biasing element 168, functions to keepthe transfer instruments 150 within the drive control mechanism 104.

In order to provide controlled travel and function of the retainer 166and retainer biasing element 168, the cartridge carrier 126 may includestructure that guides and limits movement of the retainer 166. In theillustrated embodiment, a boss 170 including two arcuate segments 172that extend between the rails 132 of the cartridge carrier 126 (see FIG.9). The arcuate segments 172 are separated by longitudinally extendingchannels 174 that slidingly receive arms 176 extending from the retainer166 (see FIG. 4). The arms 176 and/or the channels 174 may includestructure, such as the enlarged ends 180 of the arms 176, that limit themovement of the retainer 166 in a distal direction. Those of skill willappreciate that the structures, such as the boss 170 may be formedunitarily with the cartridge carrier 126, for example, or may be formedas one or more separate components.

After the drug delivery stage has completed, as shown in FIGS. 14A-14Band FIG. 10D, the drive screw 114 may be caused to move in the proximaldirection by the transmission assembly 110 and the motor 106, that is,for example, to the position illustrated in FIGS. 15A-15B and FIG. 10E.As the drive screw 114 causes motion in the proximal direction of theplunger carrier 138, such as by rotation of the drive screw 114 in thereverse or opposite direction from its earlier motion, the plungercarrier 138 engages the retainer 166 to return the retainer 166 itsoriginal position, again compressing the retainer biasing element 168 tothe position shown in FIG. 10E. As the retainer 166 and plunger carrier138 move in a proximal direction, along the axis of the drive screw 114,transfer instruments 150 are again permitted to move between the guiderecesses 156 and channels 152 and into contact with the plunger recesses154. Once this occurs, the cartridge carrier 126 is also caused to movein the proximal direction. Motion of the plunger carrier 138 and thecartridge carrier 126 in the proximal direction moves the transferinstruments 150 away from the guide recesses 156 of the fixed positionguide 158. This motion causes the transfer instruments 150 to moveradially inward as explained above, ensuring that the transferinstruments 150 disengage the guide recesses 156 and are positionedbetween the channels 152 of the cartridge carrier 126 and the recesses154 of the plunger carrier 138. This positioning of the transferinstruments 150 causes the cartridge carrier 126 and the plunger carrier138 to again move as one unified component. Movement of these unifiedcomponents in the proximal direction causes the cartridge 54 to alsomove in the proximal direction.

If a safety syringe is utilized as a cartridge 54 of the automaticinjector 50, safety mechanisms of the safety syringe may be triggered atthe end of the drug delivery stage by operation of the syringe.Accordingly, the cartridge 54 disposed in the cartridge carrier 126 ofthe automatic injector 50 will be safe for removal and disposal by theuser. Optionally, the user may reattach the rigid needle shield 60 tothe distal end of the cartridge 54, such as to the distal end of thebarrel 56, after the syringe has been used (i.e., drug delivery hascompleted). In the position illustrated in FIGS. 10e and 15a-15b , theautomatic injector 50 is reset to its original configuration and againready to accept another cartridge 54, thereby constituting a reusableautomatic injector 50.

As discussed above, one or more sensors may be utilized for safety orfor other reasons. For example, a patient sensor 165 may be utilized ata distal end of the reusable automatic injector 50 to ensure that it isin contact with the patient prior to needle injection. A cartridgesensor 160 may similarly be used to ensure that a cartridge 54 iscorrectly in position within the cartridge carrier 126 prior tooperation. Other sensors known in the art may be utilized for this orother purposes and are contemplated and encompassed within the breadthof the embodiments of the present invention. Similarly, other componentsmay optionally be utilized to enhance the safety and functionality ofthe automatic injector 50. For example, a cartridge ejector assembly 182may be utilized to removably lock and eject the cartridge 54 during andafter operation, respectively. One example of a cartridge ejectorassembly 182 is shown in FIGS. 2 and 5.

Another embodiment of a cartridge ejector assembly 184, which is shownin FIGS. 16A-16B, may alternately be provided to facilitate easy removalof the cartridge 54 from the housing 52. While the ejector assembly 184may be of any appropriate design, in the illustrated embodiment, anejector prong 186 is disposed to slide from a loaded position shown inFIG. 16A to the eject position shown in FIG. 16B as a result of movementof a toggle switch 188 disposed on the upper surface of the housing 52.When loading the cartridge 54 (not shown) into the housing 52, thetoggle switch 188 may be manually moved to a position that disposes theejector prong 186 below the level of a loaded cartridge 54, or thecartridge 54 may be utilized to depress the ejector prong 186 such thatthe ejector prong 186 is disposed subjacent the loaded cartridge 54,i.e., the position shown FIG. 16A. The ejector prong 186 of thisembodiment is coupled to the toggle switch 188 by a linkage 190 thatpivots about axis 192 to toggle the ejector prong 186 between the loadedposition shown in FIG. 16A and the eject position shown in FIG. 16B. Itwill be appreciated, however, that any appropriate design may beutilized. For example, a cartridge ejector assembly may be configured toautomatically eject a cartridge 54 upon completion of the drug dosedelivery and retraction of the cartridge 54 or the needle 58 and thecartridge 54.

As mentioned above, there are various modifications which can be madewithin the contemplation of the embodiments of the present invention.For example, alternate gear trains and actuation arrangements may beprovided. Referring to FIG. 17, in an alternate embodiment, longitudinalmovement of a plunger carrier 194 may be provided by a gear train thatincludes a rack 196 and pinion gear 198 arrangement. In other words, theelongated drive device in this embodiment includes the rack 196, with iscoupled to the plunger carrier 194. It will be appreciated that rotationof the pinion gear 198 engaged with the rack 196 causes the rack 196 andassociated plunger carrier 194 to move between proximal and distalpositions within a housing 200. The motion of the plunger carrier 194may be selectively combined with motion of a cartridge carrier 202 byway of transfer instruments 204, illustrated, for example, in FIG. 18.The transfer instruments 204 shift between detents or recesses 206, 208in the rack 196 and the cartridge carrier 202, respectively, throughchannels 210 in the cartridge carrier 202.

In order to provide rotary motion to the pinion gear 212, 214, a motor216, 218 may be disposed at an appropriate angle to provide directrotation to the pinion gear 212, 214 as shown, for example, in FIGS. 19and 20, respectively. Those of skill in the art will appreciate that thegear train may alternatively include additional gears that allow themotor to extend longitudinally within the automatic injector while stillutilizing a rack in order to impart longitudinal motion to the plungercarrier (not illustrated).

The reusable automatic injectors described above utilize a standardsyringe. However, the automatic injectors of the present invention,according to at least one other embodiment, may utilize a permanentplunger rod 228, such as is illustrated in FIG. 21, instead of astandard syringe plunger rod 66, such as is illustrated in FIGS. 11Athrough 15B. For example, the plunger interface feature 230 of plungercarrier 226, shown in FIG. 21, may include an elongated projection inthe form of an elongated rod 228 which during operation would residewithin the proximal end of the barrel 222 of cartridge 224 and with aninterface feature 230 that acts directly upon a plunger seal 220. Thisconfiguration eliminates the need for the cartridge to include a plungerrod, thus enabling the use of various cartridges 224. In one suchembodiment, after the cartridge 224 is inserted into the reusableautomatic injector, the components of the drive control mechanism wouldcause the plunger interface feature 230 to directly engage the plungerseal 220 of the cartridge 224. Axial motion in the distal direction bythe plunger carrier 226 and elongated rod 228 would cause the interfacefeature 230 to enter the proximal end of the barrel 222 of the cartridge224. After this step, the function of the components of the drivecontrol mechanism and the reusable automatic injector are as describedabove for the steps of: removal of rigid needle shield, needleinjection, drug dose delivery, and needle retraction. In suchembodiments, a final step may be performed after needle retraction toensure that the cartridge 224 is removable from the elongated rod 228and the plunger interface feature 230 and of the plunger carrier 226.Other similar configurations may be utilized for this function whileremaining within the breadth and contemplation of the present invention.

Another such an embodiment is shown in FIGS. 23A-23B. In suchembodiments, the syringe cartridge would consist of standard syringecomponents, but would not include a plunger rod. The reusable automaticinjector 210 would include a permanent plunger rod 222 which wouldconnect enter the proximal end of the syringe barrel 218 and connectwith the plunger seal 220 during operation. The permanent plunger rod222 is initially positioned between the plunger drive feature 230 a andthe proximal end of the syringe barrel 218, while passing through anaperture in a plunger nut 252. The permanent plunger rod 222 may haveone or more portions which have a radial diameter smaller than thediameter of the aperture in the plunger nut to enable free axial motionthrough the plunger nut. The permanent plunger rod 222 may have anotherportion with a screw, having a pitch diameter and a groove diameter,wherein the pitch diameter of the screw is larger than the diameter ofthe aperture in the plunger nut. This causes the permanent plunger rod222 to rotate axially as the screw portion comes in contact with theplunger nut 252.

In one such embodiment, after the syringe cartridge is inserted into thereusable automatic injector 210, the components of the drive controlmechanism 26 would cause the plunger drive feature 230 a to push uponpermanent plunger rod 222. This axial motion in the distal direction ofthe permanent plunger rod 222 would cause the distal tip of thepermanent plunger rod 222 to enter the proximal end of the syringebarrel. Once the permanent plunger rod 222 is translated axially in thedistal direction to the point where the screw portion contacts theplunger nut 252, further axial translation in the distal direction ofthe permanent plunger rod 222 causes it to rotate axially. This axialrotation screws the distal tip of the permanent plunger rod 222 into theplunger seal 220 within the barrel 218, causing them to engage and moveas a unified unit. After this step, the function of the components ofthe drive control mechanism and the reusable automatic injector 210 areas described above for the steps of: removal of rigid needle shield,needle injection, drug dose delivery, and needle retraction. In suchembodiments, a final step may be performed after needle retraction todisconnect (or unscrew) the permanent plunger rod 222 from the plungerseal 220. Since the screw portion of the permanent plunger rod 222 isnow distal to the plunger nut 252, movement of the permanent plunger rod222 in the proximal direction will cause the permanent plunger rod 222to axially rotate in the opposite direction and unscrew from the plungerseal 220. The movement of the permanent plunger rod 222 in the proximaldirection may be caused by, for example, movement of the carriage driveand carriage in the proximal direction to retract the syringe). Othersimilar configurations may be utilized for this function while remainingwithin the breadth and contemplation of the present invention.

The automatic injector may also include a cover release safety mechanismthat prevents the cartridge cover from opening during certain stages ofoperation. According to at least one embodiment of the presentinvention, a cartridge cover release safety mechanism can be operated bythe drive control mechanism as it progresses through the stages of:syringe cartridge loading, removal of rigid needle shield, needleinjection, drug dose delivery, and needle and/or cartridge retraction.In other words, the cover release safety mechanism permits opening ofthe cartridge cover only when the needle is not exposed to the user,i.e., during initial loading of the cartridge when the protective needleshield is in place and/or after drug delivery and optional retraction orshielding of the needle. The cover release safety mechanism preventsopening of the cartridge cover during other stages of operation, i.e.,when the needle is exposed for drug delivery. In this way, the coverrelease safety mechanism operates to inhibit the user's inadvertentexposure to the needle to reduce or eliminate accidental needle stickinjuries to the user, providing a highly desirable safety feature.

In the embodiment of FIGS. 22A-22E, for example, the cartridge coverrelease safety mechanism 232 is configured to be operated by thefunction of the drive control mechanism. The release actuator 234 isconfigured to slide in the proximal direction in order to release tocartridge cover (not shown) from the housing 236. The cartridge coverrelease safety mechanism 232 include a locking pin 238 that is adaptedto move between an obstructing position that prevents movement of therelease actuator 234 in a proximal direction (as shown in FIGS.22B-22D), and a retracted position that allows movement of the releaseactuator 234 in a proximal direction (as shown in FIGS. 22A and 22E).

Movement of the locking pin 238 between the obstructing and retractedpositions is at least partially controlled by a teeter 240. Movement ofthe teeter 240 is at least partially controlled by movement of theplunger carrier 242. In the illustrated views, and for the sake ofsimplicity, only the portion of the plunger carrier 242 disposed betweenthe guides 244 and the plunger interaction feature 243 are illustrated.In this embodiment, the plunger carrier includes a downwardly dependingflange 245. The teeter 240 includes a channel 246 that receives anaspect at the lower end of the locking pin 238 and a catch arm 248 thatis disposed to engage the flange 245 of the plunger carrier 242.

In order to control movement of the teeter 240, a guide pin 250 and afulcrum pin 252, both of which are fixed protrusions from the housing236. The teeter 240 includes a pair of channels 254, 256 disposedreceive the guide pin 250 and fulcrum pin 252, respectfully, to controlmovement of the teeter 240 as it slides in a plane. The teeter 240adapted to move along a predetermine path as the guide channel 254travels over the guide pin 250, movement of the slide channel 256relative to the fulcrum pin 252 allowing the teeter 240 to slide andpivot for angular changes of the teeter 240 relative to the fulcrum pin252. As the guide pin 250 travels within the guide channel 254 duringthe operation of the cartridge cover release safety mechanism 232, theguide pin 250 may be caused to removably rest within guide pin recess257 of the guide channel 254. Biasing elements 258, 260, such as springscoupled to the housing 236 (for the sake of simplicity, specificsections of the housing 236 to which the springs are coupled are notillustrated), may be utilized to direct the positioning of the cartridgecover release safety mechanism 232, specifically, the teeter 240, duringoperation.

FIG. 22A shows the locking pin 238 of the cartridge cover release safetymechanism 232 in the initial retracted position, which allows the latchrelease to be manipulated (e.g., slid axially) to open the cartridgecover for loading of the cartridge into the automatic injector. In thisposition, the flange 245 of the plunger carrier 242 is not in contactwith the corresponding catch arm 248 of the teeter 240 of the cartridgecover release safety mechanism 232.

As the syringe cartridge is loaded into the automatic injector, and theautomatic injector is activated by the user, the flange 245 of theplunger carrier 242 is caused to translate axially in the proximaldirection to retract the cartridge for removal of a rigid needleprotector, for example. As the plunger carrier 242 moves proximally, theflange 245 comes into contact with the corresponding catch arm 248 ofthe teeter 240 of the cartridge cover release safety mechanism 232,thereby pulling the catch arm 248 of the teeter 240 in the proximaldirection (see FIG. 22B). As the teeter 240 is pulled proximally, theguide channel 254 shifts upon guide pin 250 and the slide channel 256slides and pivots along the fulcrum pin 252. Guide pin 250 is caused toremovably move into position within guide pin recess 257, which causesthe locking pin 238 to shift upwards into the obstructing position nextto latch release. This prevents latch release from being moved to unlockand open the cartridge cover. The teeter 240 and locking pin 238 areretained in this position while the drive mechanism moves the plungercarrier 242 to perform the steps of drug delivery, including needleinsertion and drug dosing to the user, as shown in FIG. 22C and FIG. 22d, respectively.

As shown in FIG. 22e , upon completion of drug dose delivery and,optionally, needle and/or cartridge retraction, the plunger carrier 242is caused to translate axially in the proximal direction again. Theplunger carrier 242 again comes into contact with the correspondingcatch arm 248 of the teeter 240 of the cartridge cover release safetymechanism 232, thereby pulling catch arm 248 of the teeter 240 in theproximal direction. This motion, along with the biasing force of thebiasing elements 258, 260 causes guide pin 250 to move from the guidepin recess 257 of the guide channel 254 of the teeter 240, and slidealong the guide channel 254 to a final position where the angle of theteeter 240 pulls locking pin 238 out of the obstructing position withlatch release. At this time, the release actuator 234 may again befreely operated to open the cartridge cover (e.g., to remove the usedsyringe cartridge). In this way, by blocking the release actuator 234and maintaining the cartridge cover in a closed and locked positionduring operation of the reusable automatic injector, the user istypically prevented from exposure to the cartridge until the cartridgehas been returned to a safe (e.g., retracted, shielded, sheathed)position for the user.

As previously stated, the transfer instrument may be sized and shaped ina number of different ways while maintaining its novel functionalaspects. In at least one embodiment, the transfer instrument may be acylinder which functions to connect the components of the drive controlmechanism and facilitate the movement of the components through thevarious stages described above. Also as described above, certaincomponents may be individual components or multiple components whichwork together. These components may be separate parts which functiontogether, for ease of manufacturing for example, or be a single partthat provides more than one function. The shapes and configurationsdescribed herein are also merely exemplary and other similar shapeshaving the same functionality may be utilized, within the breadth andcontemplation of the present invention.

In a further embodiment of the present invention, a drive controlmechanism for a reusable automatic injector 50 includes a drive screw114, a cartridge carrier 126, a plunger carrier 138, and two transferinstruments 150. The drive control mechanism may further include, foreach transfer instrument, a plunger carrier recess 154 on the plungercarrier 138, a channel 152 within the cartridge carrier 126 28, and aguide recess 156 on the guide 158. These components are sized andconfigured such that the control transfer instruments are retainedwithin the drive control mechanism and the guide. For example, thecartridge carrier 126 may be a thin object having a rectangular borethrough it as a channel. The transfer instrument may reside within thechannel, but would be prevented from moving laterally along the axialplane of the cartridge carrier 126 because it is retained on all foursides. The dimensions of the transfer instrument 150 are such that thetransfer instrument is always removably engaged with two components ofthe drive control mechanism 104 simultaneously. For example, in somestages of operation the transfer instrument 150 is removably engagedwith the guide recess 156 of the guide 158 and the channel 152 of thecartridge carrier 126. In other stages of operation, the transferinstrument 150 is removably engaged with the channel 152 of thecartridge carrier 126 and the plunger carrier recess 154 of the plungercarrier 138. The drive control mechanism functions by forcing thetransfer instrument between the plunger carrier recess 154 of theplunger carrier 138, the channel 152 within the cartridge carrier 126,and the guide recess 156 of the guide 158, such that a single motor 106and transmission assembly 110 acting upon a drive screw 114 can controlthe function of the multiple components, as described above.

The reusable automatic injectors of the present invention are able toaccommodate partially or fully filled cartridges 54, 224 of varyingcapacity, including 1 mL cartridges 54, 224. The reusable automaticinjector could be used with retractable or safety syringes, includingprefilled syringes, as well as with non-safety syringes. When used witha non-safety syringe, the cartridge 54, 224 is fully withdrawn back intothe reusable automatic injector housing 52 after the injection toprotect the user from exposed needles 58. Following the injectioncomplete signal, the user can re-cap the non-safety syringe whilst itremains in the reusable automatic injector housing 52 with no risk of aneedle 58 stick injury as the needle 58 point is contained inside thehousing 52. The reusable automatic injector or cartridge cover 72 canthen be opened and the used cartridge 54, 224 can be safely disposed ina sharps container. The reusable automatic injector would thereforeprovide a safe injection for non-safety syringes in addition to workingwith most retractable needle syringes. The present invention alsoprovides reusable auto-injectors which are ergonomic, easy-to-use andaesthetically similar to products currently employed byself-administering patients. The automatic injectors of the presentinvention provide sufficient force at suitable speeds to simulate aninjection by a nurse or doctor, yet provide the freedom of use forself-administering patients. The reusable automatic injectors of thepresent invention are also configured to withstand frequent use, such asdaily use, over an extended period of time. The energy source whichpowers the reusable automatic injectors may similarly be replaceable,rechargeable, or otherwise provide power for use of the injectors overan extended period of time. The present invention thereby provides areusable automatic injector with integrated safety mechanisms, enabledby incorporating a retractable needle syringe within the reusableautomatic injector, in a convenient and easy-to-use package forpatients.

One or more of the embodiments described above may provide additionaldesirable features to the patient. For example, the novel automaticinjectors of the present invention may utilize existing or additionalcomponents within the housing to limit the depth of needle insertion. Inone such embodiment, features located on the housing or the guide may beutilized for this purpose. In another embodiment, mechanical limits maybe integrated into the drive control mechanism, the cartridge carrier,the plunger carrier, or the drive screw to limit the range of travel ofthe syringe needle into the patient. Similarly, as described above, oneor more components may be employed to automatically remove the needleshield from the syringe needle upon activation of the reusableauto-injector.

In another embodiment, a single automatic injector according to theinvention may be adjusted to accommodate cartridges including needles ofvarious lengths. In this way, a single automatic injector may beutilized, for example, for intramuscular injections and subcutaneousinjections. In adjusting for various needle lengths, the automaticinjector may include a mechanical adjustment and/or an electricaladjustment, for example, by way of the user interface. The depth ofneedle insertion may be adjusted based upon the movement of thecartridge carrier within the housing, that is, as the cartridge andneedle are moved to the position illustrated in FIGS. 13A and 13B.

According to another aspect of the invention, the processor of someembodiments may be programmed to precisely control the dose ofmedication administered. For example, when a cartridge includes a largervolume than required for administration, the automatic injector may bedirected to dispense the unneeded volume prior to placement on thetarget tissue. The user interface may be utilized to program theautomatic injector to dispense the unneeded volume prior toadministration, for example, so long as the patient sensor 165 is notdepressed. Accordingly, the automatic injector may be configured toexpend a portion of the drug dosage to a reservoir or to theenvironment, prior to needle injection and drug dose delivery into auser, in order to reduce or adjust drug volume. The automatic injectormay then be placed against the target tissue, actuating the patientsensor 165 to allow for dose administration. In another embodiment, theautomatic injector may be programmed to insert the needle, administerthe programmed volume of medication, and then move the cartridge in theproximal direction to retract the needle from the target tissue.

In further embodiments, the automatic injector may include one or moreoverrides. For example, the automatic injector may include an electronicoverride that may be actuated by way of the user interface.Alternatively or additionally, the automatic injector may include amanual override. For example, removal of the automatic injector from thetarget tissue such that the patient sensor 165 is no longer activatedmay cause the plunger carrier to cease progression and the cartridgecarrier to retract the needle into the housing.

In another embodiment, the present invention relates to the method formanufacturing automatic injectors. The method includes the steps ofassembling a drive control mechanism which includes an elongated drivedevice, such as a drive screw 114 or a rack 196, a cartridge carrier126, a plunger carrier 138, and one or more control transfer instruments150. The drive control mechanism may further include one or more plungercarrier recess(es) 154 within the plunger carrier 138, channels 152within the cartridge carrier 126, and guide recess(es) 156 of the guide158. These components are sized and configured such that the controltransfer instruments 150 (e.g., pucks) are retained within the drivecontrol mechanism and the guide. The method further includes the step ofattaching a guide and a support housing 52 to the drive controlmechanism. The method may further include the steps of attaching one ormore of: an energy source, a motor 106, a transmission assembly 110, acontrol system such as a microprocessor, wherein the transmissionassembly 110 is made to contact the drive screw 114. A cartridge 54 orhousing 52 cover 72 may also be attached on the top side of theautomatic injector.

In yet another embodiment, the present invention relates to a method ofuse for an automatic injector. The method includes the steps of:inserting a cartridge 54 into the carriage contained in a housing 52 ofthe automatic injector and activating the automatic injector toinitiate, optionally, one or more of: removal of a needle shield 60,injection of a needle 58 into a patient, delivery of drug through theneedle 58 to the patient, retraction of the needle 58 from the patientinto the housing 52, and removal of the cartridge 54 from the cartridgecarrier 126. Furthermore, optionally, the method of use may include thestep of expending a portion of the drug dosage to a reservoir or to theenvironment, prior to needle injection and drug dose delivery into auser, in order to reduce or adjust drug dose volume. Similarly,optionally, the method of use may include the step of adjusting therange of axial translation of the drive mechanism (and therefore thesyringe cartridge) to accommodate different needle lengths and/orinjection depths. The method may further include the steps of opening acartridge cover 72 to access an interior of the automatic injector priorto the insertion of a cartridge 54 into the cartridge carrier 126, andthe step of closing the cartridge cover 72 after the cartridge 54 hasbeen loaded into the cartridge carrier 126. The method may similarlyinclude the step of opening the cartridge 54 or housing 52 cover 72 toaccess an interior of the automatic injector after the retraction of theneedle 58 to remove the used cartridge 54. The user may optionallyreattach the needle shield 60 to the cartridge 54 prior to removal ofthe cartridge 54 from the cartridge carrier 126. After the usedcartridge 54 has been removed from the cartridge carrier 126 of theautomatic injector, the automatic injector is reset and ready to acceptanother cartridge 54.

The embodiments shown and detailed herein disclose only a few possiblevariations of the present invention; other similar variations arecontemplated and incorporated within the breadth of this disclosure. Aswould be readily appreciated by an ordinarily skilled artisan, a numberof parameters, shapes, and dimensions described above may be modifiedwhile remaining within the breadth and scope of the present invention.For example, the distance that the cartridge carrier 126 moves in thedistal direction may be adjusted to ensure that a predetermined depth ofneedle 58 insertion is met. Additionally or alternatively, otherstandard components such as stop members to prevent the travel of thecarrier may be utilized to achieve this or similar functions. Otherfeatures may similarly be adjustable. For example, the automaticinjector may be configured to accept different gear ratios and drivescrew or rack pitches to provide desired injection speeds for a range ofdrug viscosities and patient requirements. The present inventionprovides drive control mechanisms, reusable automatic injectors, methodsof manufacturing such automatic injectors, and their methods of use. Asstated above, the drive control mechanisms and reusable automaticinjectors may be utilized in a number of different configurations andmay themselves comprise of one or more components. Other components maysimilarly be single components, unified components, or multi-purposecomponents, as described in the embodiments discussed above. Such novelautomatic injectors may be employed by, for example, patients who arerequired to self-inject their medication on a regular or long-termbasis. Accordingly, similar to the examples provided above, the novelreusable auto-injectors of the present invention may be configured,modified, and utilized to initiate drug delivery and activate needleretraction in any number of configurations while remaining within thebreadth and scope of the present invention. Thus, it is intended thatthe present invention covers the modifications and variations of thisinvention provided they come within the scope of the appended claims andtheir equivalents.

The incorporation of the syringe retraction or the integrated needleretraction syringe into a reusable auto-injector enables patients tosafely self-administer pharmaceutical treatment in an easy-to-usemanner. The incorporation of the novel safety syringe features anddesigns into the reusable automatic injector provides a true end of doseindicator. Additionally, a standard syringe may be utilized andretracted into the body of the automatic injector to provide needlesafety and to indicate that the dose is complete. While the syringesdescribed herein may have integrated safety features, the automaticinjectors of the present invention may be utilized with conventionalsyringes that lack such features.

The incorporation of such syringes into a disposable or reusableautomatic injector extends the integrated safety mechanisms of thesyringes into an automated drug delivery device that is highly desirableby patients. More specifically, automatic injectors that employ theintegrated needle retraction safety syringes described herein mayutilize the pre-filled syringe's retraction mechanism instead of, or inaddition too, other retraction mechanisms of the automatic injector suchas the reverse drive mechanisms. Additionally, such automatic injectorsalso solve a significant unmet need is for an automatic injector with atrue end of dose indicator. Currently visual, tactile or audibleindicators are generally linked to the end of stroke or some othermechanical mechanism and not to the end of dose. The integrated needleretraction safety syringe retracts the needle into the syringe barrel,removing it from the patient's skin, once the dose is complete.Therefore, incorporating such integrated safety syringes into anautomatic injector incorporates this true end of dose indicator. Theembodiments of the present invention provide drive mechanisms, automaticinjector configurations, and methods for manufacturing and usingreusable automatic injectors. Such novel devices may be employed by, forexample, patients who are required to self-inject their medication on aregular or long-term basis.

It will be appreciated that the foregoing description provides examplesof the disclosed system and technique. However, it is contemplated thatother implementations of the disclosure may differ in detail from theforegoing examples. All references to the disclosure or examples thereofare intended to reference the particular example being discussed at thatpoint and are not intended to imply any limitation as to the scope ofthe disclosure more generally. All language of distinction anddisparagement with respect to certain features is intended to indicate alack of preference for those features, but not to exclude such from thescope of the disclosure entirely unless otherwise indicated.

The use of the terms “a” and “an” and “the” and “at least one” andsimilar referents in the context of describing the invention (especiallyin the context of the following claims) are to be construed to coverboth the singular and the plural, unless otherwise indicated herein orclearly contradicted by context. The use of the term “at least one”followed by a list of one or more items (for example, “at least one of Aand B”) is to be construed to mean one item selected from the listeditems (A or B) or any combination of two or more of the listed items (Aand B), unless otherwise indicated herein or clearly contradicted bycontext.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context.

Accordingly, this disclosure includes all modifications and equivalentsof the subject matter recited in the claims appended hereto as permittedby applicable law. Moreover, any combination of the above-describedelements in all possible variations thereof is encompassed by thedisclosure unless otherwise indicated herein or otherwise clearlycontradicted by context.

We claim:
 1. A method of operating an automatic injector to inject afluid from a cartridge, the method comprising: disposing the cartridgein the automatic injector with at least a portion of a barrel disposedwithin a cartridge carrier, and a plunger assembly disposed forconfrontation with a plunger carrier, a needle end of the cartridgedefining a distal end of the automatic injector and an opposite end ofthe cartridge defining a proximal end of the automatic injector;coupling the cartridge carrier to the plunger carrier, the couplingincluding moving at least one transfer instrument from a first position,in which the transfer instrument engages only one of the either thecartridge carrier or the plunger carrier, to a second position, in whichthe transfer instrument engages both the cartridge carrier and theplunger carrier to couple the cartridge carrier and the plunger carriertogether for contemporaneous movement; utilizing a single drivemechanism to move the plunger carrier and the cartridge carrier toadvance the cartridge in an axial direction toward the distal end;decoupling the cartridge carrier from the plunger carrier; utilizing thedrive mechanism to move the plunger carrier in the axial directiontoward the distal end to dispense the fluid; and retracting the plungercarrier in an axial direction toward the proximal end.
 2. The method ofclaim 1 further including actuating the automatic injector.
 3. Themethod of claim 1 further including covering the cartridge with acartridge cover.
 4. The method of claim 1 further including removablycoupling the cartridge carrier to the plunger carrier and utilizing thedrive mechanism to move the cartridge carrier and the plunger carrier inthe axial direction toward the proximal end following dispensing of thefluid.
 5. The method of claim 1 further including utilizing the singledrive mechanism to move the removably coupled cartridge carrier andplunger carrier in the axial direction toward the proximal end todisengage a needle shield from the cartridge prior to moving the plungercarrier and cartridge carrier in the axial direction toward the distalend.
 6. The method of claim 1 wherein utilizing a single drive mechanismto move the plunger carrier and the cartridge carrier includes impartingmovement to an elongated drive device coupled to the plunger carrier. 7.The method of claim 6 including operating a motor to impart movement tothe elongated drive device.
 8. The method of claim 7 wherein the step ofoperating the motor includes coupling an output of the motor to theelongated drive device with at least one gear.
 9. The method of claim 1wherein decoupling the cartridge carrier from the plunger carrierincludes moving the at least one transfer instrument from the secondposition to the first position.
 10. The method of claim 1 wherein thetransfer instrument engages an opening in only one of the either thecartridge carrier or the plunger carrier in the first position, andwherein the transfer instrument engages openings in both of thecartridge carrier and the plunger carrier, in the second position. 11.The method of claim 1 wherein wherein the transfer instrument engages anopening in the cartridge carrier and an opening in a housing in thefirst position and wherein the transfer instrument engages the openingin the cartridge carrier and an opening in the plunger carrier in thesecond position.
 12. The method of claim 1 wherein utilizing a singledrive mechanism includes imparting movement to a threaded drive screwand drivingly engaging at least portion of the threads of the threadeddrive screw with threads of the plunger assembly.
 13. The method ofclaim 1 further including actuating an ejector to eject the cartridgefollowing retraction.
 14. The method of claim 1 further includingoperating a user interface.
 15. The method of claim 1, furthercomprising: removing the cartridge from the housing; disposing a secondcartridge in the housing; and actuating the automatic injector todispense fluid from the second cartridge.
 16. A method of operating anautomatic injector to inject a fluid from a cartridge, the methodcomprising: disposing the cartridge in the automatic injector with atleast a portion of a barrel disposed within a cartridge carrier, and aplunger assembly disposed for confrontation with a plunger carrier, aneedle end of the cartridge defining a distal end of the automaticinjector and an opposite end of the cartridge defining a proximal end ofthe automatic injector; removably coupling the cartridge carrier to theplunger carrier; utilizing a single drive mechanism to move the plungercarrier and the cartridge carrier to advance the cartridge in an axialdirection toward the distal end; decoupling the cartridge carrier fromthe plunger carrier; utilizing the drive mechanism to move the plungercarrier in the axial direction toward the distal end to dispense thefluid; recoupling the cartridge carrier to the plunger carrier; andutilizing the drive mechanism to move the cartridge carrier and theplunger carrier in the axial toward the proximal end followingdispensing of the fluid.
 17. A method of operating an automatic injectorto inject a fluid from a cartridge, the method comprising: disposing thecartridge in the automatic injector with at least a portion of a barreldisposed within a cartridge carrier, and a plunger assembly disposed forconfrontation with a plunger carrier, a needle end of the cartridgedefining a distal end of the automatic injector and an opposite end ofthe cartridge defining a proximal end of the automatic injector;coupling the cartridge carrier to the plunger carrier; utilizing asingle drive mechanism to move the plunger carrier and the cartridgecarrier to advance the cartridge in an axial direction toward the distalend, the utilizing the single drive mechanism including impartingmovement to a threaded drive screw and drivingly engaging at leastportion of threads of the threaded drive screw with threads of theplunger assembly; decoupling the cartridge carrier from the plungercarrier; utilizing the drive mechanism to move the plunger carrier inthe axial direction toward the distal end to dispense the fluid; andretracting the plunger carrier in an axial direction toward the proximalend.